A Study to Evaluate the Effect of Mechanical Ventilation on the Inferior Vena Cava Collapsibility Index (IVCCI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naeem Ali, MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01136109
First received: May 26, 2010
Last updated: March 21, 2013
Last verified: March 2013

May 26, 2010
March 21, 2013
October 2009
February 2013   (final data collection date for primary outcome measure)
Determine the effect of an increase in positive end-expiratory pressure on intrathoracic pressure variables in patients with acute respiratory failure. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  1. Determine the effect on inferior vena cava collapsibility index of an increase in positive end-expiratory pressure (and resultant change in mean airway pressure) in patients with acute respiratory failure.
  2. Determine the effect on central venous pressure of an increase in positive end-expiratory pressure (and resultant change in mean airway pressure) in patients with acute respiratory failure.
  3. Determine the effect on mean airway pressure of an increase in positive end-expiratory pressure in patients with acute respiratory failure.
Determine the effect of an increase in PEEP on intrathoracic pressure variables in patients with acute respiratory failure. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  1. Determine the effect on IVCCI of an increase in PEEP (and resultant change in mean airway pressure) in patients with acute respiratory failure.
  2. Determine the effect on CVP of an increase in PEEP (and resultant change in mean airway pressure) in patients with acute respiratory failure.
  3. Determine the effect on mean airway pressure of an increase in PEEP in patients with acute respiratory failure.
Complete list of historical versions of study NCT01136109 on ClinicalTrials.gov Archive Site
  • Determine the inter-rater reliability in obtaining inferior vena cava collapsibility index ultrasound images. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Determine the relationship between central venous pressure and inferior vena cava collapsibility index at varying levels of mean airway pressure (MAP). [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Determine the inter-rater reliability in obtaining IVCCI ultrasound images. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Determine the relationship between CVP and IVCCI at varying levels of mean airway pressure (MAP). [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Evaluate the Effect of Mechanical Ventilation on the Inferior Vena Cava Collapsibility Index
A Prospective Pilot Study to Evaluate the Effect of Mechanical Ventilation on the Inferior Vena Cava Collapsibility Index

Previous research has shown that the Inferior Vena Cava Collapsibility Index (IVCCI) can be used to assess volume status. One limitation of the previous work is that changes in intra-thoracic pressure can influence this measurement, and the magnitude of this effect has never been described. The investigators aim is to correlate the degree of change in IVCCI with the set degree of change in intra-thoracic pressure in a heterogeneous population of critically ill patients.

Initially eligible patients will be those admitted to the OSU MICU and 8ICU within the prior 48 hours. These patients will be screened for predetermined exclusion criteria. Eligible patients will have their IVCCI measured and baseline peak and plateau pressures noted. For those patients meeting a second set of criteria, a common ventilator maneuver will be preformed. The positive end-expiratory pressure will be increased by 5-10 cm/H20 pressure. This procedure will be aborted if ANY safety criteria are exceeded. During the interval, the IVCCI will be re-measured, the ventilator settings will be recorded, and the ventilator will be return to the initial settings. Since changes of these same magnitude are made daily in clinical practice, the risks to the patients in this study will be minimal and no more than that experienced in the course of usual care.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

InpatientSample

Respiratory Failure
Not Provided
  • Bedside ultrasound only
    Bedside ultrasound to determine the dimensions of the inferior vena cava
  • Ultrasound with ventilator changes
    Bedside ultrasound to determine the dimensions of the inferior vena cava pre and post ventilator changes.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age>17 years
  2. Current use of mechanical ventilation through an endotracheal tube.
  3. Admitted to ICU within last 48 hours

Exclusion Criteria:

  1. Severe COPD by history (documented FEV1<50% predicted or CT evidence of emphysema)
  2. Current suspected Asthma Exacerbation
  3. Profound Hypoxia defined as a FiO2 requirement >90% or a PEEP >10 mmHg
  4. Patient-ventilator desynchrony or active agitation
  5. Unstable O2 requirement as determined by the primary clinical team.
  6. Prisoners
  7. Bedside clinician refusal (physician or treating nurse).

Exclusion Criteria for ventilator changes:

  1. Cardiovascular instability (any increase in rate of vasopressors or i.v. fluid bolus for hypotension within the last four hours)
  2. Current PEEP requirements of >15cmH2O
  3. Current SpO2 of <88%.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01136109
2009H0143
No
Naeem Ali, MD, The Ohio State University
Naeem Ali, MD
Not Provided
Principal Investigator: Naeem Ali, M.D. Ohio State University
Ohio State University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP